enVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL)

FDA Premarket Approval P910056 S040

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

An alternate milling process and an optional cleaning/drying step prior to batch milling for the envista hydrophobic acrylic intraocular lenses, models mx60, mx60e, mx60t, mx60et and mx60pl

DeviceenVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL)
Generic NameIntraocular Lens
ApplicantBausch & Lomb, Inc.
Date Received2019-12-20
Decision Date2020-01-16
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Bausch & Lomb, Inc. 50 Technology Drive irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P910056Original Filing
S041 2019-12-23 30-day Notice
S040 2019-12-20 30-day Notice
S038 2019-07-03 30-day Notice
S036 2019-04-03 Normal 180 Day Track
S035 2018-10-16 30-day Notice
S034 2018-10-02 30-day Notice
S031 2018-07-06 30-day Notice
S030 2018-06-11 30-day Notice
S029 2017-12-15 30-day Notice
S028 2017-11-08 30-day Notice
S027 2017-10-30 Panel Track
S026 2017-10-02 30-day Notice
S024 2016-10-21 Normal 180 Day Track
S023 2016-06-03 30-day Notice
S022 2016-05-03 30-day Notice
S021 2015-11-06 30-day Notice
S020 2015-03-30 30-day Notice
S019 2015-03-25 135 Review Track For 30-day Notice
S018 2014-08-11 30-day Notice
S017 2014-05-05 Normal 180 Day Track
S016 2014-03-27 30-day Notice
S015 2013-12-05 30-day Notice
S014 2013-01-28 135 Review Track For 30-day Notice
S013 2012-09-07 Real-time Process
S012 2012-08-06 30-day Notice
S011 2012-07-23 Real-time Process
S010 2011-09-12 Normal 180 Day Track
S008 2003-06-11 Real-time Process
S007 1999-11-24 Real-time Process
S006 1997-03-06 Normal 180 Day Track
S003 1992-06-16 Normal 180 Day Track
S002 1992-04-28 Normal 180 Day Track
S001 1991-11-06 Normal 180 Day Track

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